GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
FDA 510(k) K153716 · Gpc Medical, Ltd.
510(k) numberK153716
Submission
- Device name
- GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
- Applicant
- Gpc Medical, Ltd.
New Delhi, IN - Received
- December 24, 2015
- Decision date
- May 17, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K203811 | GPC Intraheal Intramedullary Nailing SystemHSB · Traditional | 02/10/2022SE |
| K210198 | GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes…HRS · Traditional | 01/07/2022SE |
| K163096 | GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemNKB · Traditional | 03/31/2017SE |
| K143245 | GPC Intramedullary Nailing SystemsHSB · Traditional | 09/30/2015SE |
| K092493 | GPC Bone Plaes and Bone Screw & GPC Dhs/Dcs Plate SystemHRS · Traditional | 03/29/2010SE |
Questions and answers
When was GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. cleared by the FDA?
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. (K153716) received a 510(k) decision of Substantially Equivalent on May 17, 2016, 145 days after the submission was received.
What is the product code of K153716?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.